Events

Safety Alert for Alaris PC unit

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by CareFusion.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-01-07
  • Event Date Posted
    2014-01-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140107.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: carefusion alaris pc unit the united states food and drug administration (fda) posted a medical device safety alert concerning the alaris pc unit model 8000 and 8015 with alaris patient controlled analgesia (pca) module model 8120 and auto id barcode scanner model 8600 manufactured by carefusion. the alaris pc unit is the central programming, monitoring and power supply component for the alaris system. the alaris pca pump is one of the modules offer under the alaris system. the auto id is a barcode scanner. according to the manufacturer, the alaris pc unit (model 8000 and 8015) was recalled because the alaris pc unit will produce an audible alarm and display a system error message. for details, please visit the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-0534-2014&w=01012014&lang=eng if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 7 january2014.

Device

Alaris PC unit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Carefusion Alaris PC unit
  • Manufacturer
    CareFusion

Manufacturer

CareFusion